Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe Atopic Dermatitis
2 other identifiers
interventional
148
6 countries
38
Brief Summary
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2019
Typical duration for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2019
CompletedStudy Start
First participant enrolled
December 9, 2019
CompletedFirst Posted
Study publicly available on registry
December 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2022
CompletedResults Posted
Study results publicly available
September 28, 2023
CompletedSeptember 28, 2023
August 1, 2023
2.6 years
November 4, 2019
July 19, 2023
August 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline to Week 16 in EASI Score
The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.
Week 16
Secondary Outcomes (27)
Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
Week 16
Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
Week 16
Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
Week 16
Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16
Week 16
Percentage of Subjects Achieving a Reduction of ≥ 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Week 16
- +22 more secondary outcomes
Study Arms (4)
MEDI3506 at dose level 1
EXPERIMENTALParticipant will receive multiple doses of MEDI3506 at dose level 1.
MEDI3506 at dose level 2
EXPERIMENTALParticipant will receive multiple doses of MEDI3506 at dose level 2.
MEDI3506 at dose level 3
EXPERIMENTALParticipant will receive multiple doses of MEDI3506 at dose level 3.
Placebo
PLACEBO COMPARATORParticipant will receive multiple doses of Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 to 65 years inclusive at the time of consent.
- Body mass index between 19.0 and 40.0 kg/m2 inclusive.
- Documented history of chronic AD, for at least 1 year prior to screening Visit 1.
- Meets at minimum 1 of the criteria, as follows:
- History of inadequate response to topical medications for AD
- Subject intolerance to treatment with topical medications for AD, or
- Topical medications are otherwise medically inadvisable
- AD that affects ≥ 10% of the body surface area (BSA).
- An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).
- An IGA score of ≥ 3.
You may not qualify if:
- Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram \[ECG\]) or from safety laboratory analysis.
- Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
- Known active allergic or irritant contact dermatitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (38)
Research Site
Birmingham, Alabama, 35209, United States
Research Site
Santa Monica, California, 90404, United States
Research Site
Jacksonville, Florida, 32256, United States
Research Site
Miami, Florida, 33180, United States
Research Site
Orlando, Florida, 32806, United States
Research Site
Baton Rouge, Louisiana, 70808, United States
Research Site
Charlotte, North Carolina, 28277, United States
Research Site
Tulsa, Oklahoma, 74136, United States
Research Site
Providence, Rhode Island, 02903, United States
Research Site
Spartanburg, South Carolina, 29303, United States
Research Site
Memphis, Tennessee, 38119, United States
Research Site
San Antonio, Texas, 78213, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Box Hill, 3128, Australia
Research Site
Carlton, 3053, Australia
Research Site
East Melbourne, 3002, Australia
Research Site
Fremantle, 6160, Australia
Research Site
Berlin, 10117, Germany
Research Site
Dresden, 01307, Germany
Research Site
Hamburg, 20246, Germany
Research Site
Mahlow, 15831, Germany
Research Site
Bialystok, 15-453, Poland
Research Site
Kielce, 25-355, Poland
Research Site
Lodz, 90-436, Poland
Research Site
Poznan, 60-681, Poland
Research Site
Skierniewice, 96-100, Poland
Research Site
Wroclaw, 50-566, Poland
Research Site
Alcobendas, 28100, Spain
Research Site
Leganés, 28915, Spain
Research Site
Seville, 41003, Spain
Research Site
Corby, NN18 9EZ, United Kingdom
Research Site
High Wycombe, HP11 2QW, United Kingdom
Research Site
Kenilworth, CV8 1JD, United Kingdom
Research Site
Northwood, HA6 2RN, United Kingdom
Research Site
Romford, RM1 3PJ, United Kingdom
Research Site
Shipley, BD18 3SA, United Kingdom
Research Site
Sidcup, DA14 6LT, United Kingdom
Research Site
Wokingham, RG40 1XS, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigation product only will be prepared and administered by unmasked personnel. All subjects will receive the same number of injections at each dose.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2019
First Posted
December 26, 2019
Study Start
December 9, 2019
Primary Completion
July 21, 2022
Study Completion
September 20, 2022
Last Updated
September 28, 2023
Results First Posted
September 28, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.